Extended indication Renal cell carcinoma (RCC), advanced, unresectable - first-line in combination with bevacizumab.
Therapeutic value No judgement
Total cost 28,250,000.00
Registration phase Clinical trials

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Main indication Kidney cancer
Extended indication Renal cell carcinoma (RCC), advanced, unresectable - first-line in combination with bevacizumab.
Proprietary name Tecentriq
Manufacturer Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks An engineered anti-PD-L1 antibody.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date April 2018
Expected Registration May 2019
Orphan drug No
Registration phase Clinical trials
Additional remarks Sluis-product, financieel arrangement van toepassing.

Therapeutic value

Current treatment options Sunitinib
Therapeutic value No judgement
Substantiation Improved PFS versus sunitinib (IMmotion151).
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT02420821; Scrip

Expected patient volume per year

Patient volume

< 565

Market share is generally not included unless otherwise stated.

References NKR; Ned Tijdschr Geneeskd. 2008;152:371-5
Additional remarks Ned Tijdschr Geneeskd.: Incidentie van gemetastaseerd niercelcarcinoom in 2007 lag op 650 patienten. Op basis van de NKR: In 2016 waren er 565 nieuwe patiënten met stadium IV niercelcarcinoom (dit is excl. niet-carcinomen en niet PA bevestigde tumoren). Daarbij komen dan nog de patiënten die progressie vertonen na stadium I-III. Dat zal op jaarbasis ongeveer 1-8% zijn (afhankelijk van het stadium 1% van de stadium I tumoren in een jaar en 8% van de stadium III tumoren in een jaar). Een deel hiervan zal in aanmerking komen voor een behandeling.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Medicijnkosten.nl; drugs.com
Additional remarks Verwacht in lijn met andere immunotherapieën. €1098,16 voor nivolumab 10mg per ml fl 10 ml; €3355,96 voor pembrolizumab 25 mg per ml fl 4ml. In de VS $9.000 dollar voor 1200 mg 20 ml.

Potential total cost per year

Total cost

28,250,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Er lopen meerdere PhIII studies.
Additional remarks Gastric and TNBC worden later verwacht (2020).

Other information

There is currently no futher information available.